Medical devices and methods of use

ABSTRACT

A single-use medical endoscope with an elongate shaft carrying a distal image sensor, with a flex circuit component having a distal end electrically coupled to the image sensor and a proximal tail end of the flex circuit extending outwardly from the endoscope handle to a flex circuit connector assembly.

RELATED APPLICATIONS

This application is a non-provisional of U.S. Provisional ApplicationNo. 63/201,972 filed May 20, 2021, the entirety of which is incorporatedby reference herein.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to medical devices, and more particularlyto medical devices configured with a distal imaging sensor, such as anendoscope with a working channel therein or a tool with a working endthat carries at least one image sensor.

Endoscopes are used in a wide variety of minimally invasive surgicalprocedures, including laparoscopy, arthroscopy, and the like. Ofparticular interest to the present application, hysteroscopy is aminimally invasive procedure for resecting fibroids and performingsimilar interventions in a patient's uterus. Hysteroscopy utilizes ahysteroscope which is a type of endoscope that carries optics forviewing, a light source for illumination, and a working channel.Interventional tools, such as a resecting device, an electrosurgicalcautery device, forceps, and the like, can be introduced through theworking channel of the hysteroscope to perform a therapeutic procedurewhile the patient's uterus is distended with a fluid media. Thehysteroscope is often introduced through a passage in a transcervicalsheath which also allows for fluid inflows and outflows into and out ofthe uterine cavity.

Heretofore, to accommodate the optics, light sources, and the workingchannel, hysteroscopes have had large diameters which require passage ofa large sheath through the cervix, further requiring dilation of thecervix prior to insertion. Cervical dilation requires stretching thecervix with a series of dilators of increasing diameter and can betraumatic for many patients.

For these reasons, it would be desirable to provide hysteroscopes havingrelatively small diameters to reduce or eliminate the need to dilate thepatient's cervix prior to introduction of the hysteroscope. It would befurther desirable to provide methods utilizing such hysteroscopes andstill further desirable to provide similar designs and methods for alltypes of endoscopes used in a variety of minimally invasive procedures,including, laparoscopy, arthroscopy, and the like. At least some ofthese objectives will be met by the inventions described and claimedhereinafter.

SUMMARY OF THE INVENTION

The present invention provides an endoscope and a method for using theendoscope in hysteroscopies and other endoscopic surgical procedures.The endoscope design of the present invention provides a low profile orcross-section, which facilitates introduction through small bodypassages, such as patient's cervix, and into body cavities, such as apatient's uterus. Particular endoscope designs incorporate a number offeatures that can be used alone or in combination to achieve the certainobjectives of the present invention, such as a reduced endoscope shaftdiameter and reduced patient trauma during introduction of theendoscope.

In a first aspect, an endoscope constructed in accordance with theprinciples of the present invention comprises a handle coupled to ashaft having a diameter and extending about a longitudinal axis to aworking end. The shaft includes an outer sleeve that is axially moveablerelative to an inner sleeve, and an image sensor is carried by aflexible spring-type member attached to a distal end of the innersleeve. The flexible member has at least one living hinge portion andoften has two living hinge portions, which can be actuated betweentensioned and repose positions. The image sensor is typicallyrectangular and has a diagonal dimension measured from a first corner toa second diagonally opposed corner. The outer sleeve of the shaft istypically cylindrical and has a diameter. The inner sleeve has a workingchannel therein which extends through handle and the shaft opentermination in a distal end of the shaft. The outer sleeve can be movedfrom a first distal position to a second proximal position relative tothe inner sleeve and working channel therein. Such movement of the outersleeve positions the image sensor distally from the bore of the outersleeve and allows the spring force inherent in a living hinge portion ofthe flexible member and move the image sensors away from thelongitudinal axis of the shaft. When the working end is moved from thefirst insertion position to the second deployed position, the spacewithin the outer sleeve beyond the distal end of the inner sleeve, whichcomprises a distal portion of the overall working channel, increases incross-section to accommodate a tool as it is introduced through anendoscope. In accordance with the present invention, a combination orsum of (1) the diagonal dimension of the image sensor and (2) a diameterof the working channel is greater than a diameter dimension of theshaft. These relative dimensions can maximize the cross-section of theworking channel through the endoscope in the deployed position whileminimizing the diameter of the shaft in the insertion position forintroducing the shaft through a body passage into a working space in apatient.

In specific examples of this endoscope, the ratio of the diagonaldimension of the image sensor to the shaft diameter is at least 0.5:1,and often the ratio is greater than 0.6:1. In still other specificexamples, the ratio of the working channel cross-section to the shaftdiameter is at least 0.5:1, and often the ratio is greater than 0.6:1.

In still further specific examples, the image sensor is carried in agenerally transverse or orthogonal orientation relative to the shaft'slongitudinal axis with a distal-facing optical axis and field of view.The optical axis is adjusted when the working end is moved from theinsertion position to the deployed position. In one example, the opticalaxis of the image sensor may change as an interventional tool isintroduced through the working channel, wherein the tool abuts anddeflects the flexible member to assist in moving the image sensor awayfrom the longitudinal axis of the shaft. In another specific example,movement of the outer sleeve distally while a tool shaft extends throughthe working channel can be used to actuate a second living hinge portionof the flexible member to alter or adjust the optical axis and field ofview of the image sensor.

In another aspect of the present invention, the single-use endoscopeincludes an image sensor, two LEDS, and at least one accelerometermounted on a single flex circuit that extends through the endoscope froma cable that is configured with a connector at a proximal end thereof.The use of such a single flex circuit eliminates the need for a circuitboard and connection in the handle, which makes the device economical.Further, the flex circuit has electrically insulated layers exposed onall surfaces, which are capable of shielding the electrical leads of theimage sensor and accelerometer from any possible electricalinterference, including any interference from an electrosurgical toolused with the endoscope.

In another aspect of the present invention, a method for imaging andtreating a body cavity comprises providing an endoscope having any ofthe features and combinations of features described above, for example,including an elongated member extending about a central or longitudinalaxis through a handle, proximal shaft portion and a distal shaftportion, an image sensor carried by the distal shaft portion, and aworking channel extending through the handle and shaft. The endoscope isadvanced through a body passage in a first reduced-diameterconfiguration using the image sensor. Thereafter, a working space in abody cavity is imaged using the image sensor, and the image sensor isactuated to move away from or diverge from, the axis of the endoscopeshaft. A tool may then be advanced through the working channel of theendoscope into the body cavity. The tool may then be used to treat thebody cavity while the tool and the image sensor remain diverged relativeto each other.

BRIEF DESCRIPTION OF THE DRAWINGS

Additional aspects of the invention will become clear from the followingdescription of illustrative embodiments and from the attached drawings,in which:

FIG. 1 is a perspective view of an embodiment of an endoscopecorresponding to the invention, with an enlarged view of the distalworking end.

FIG. 2 is a perspective view of an inner sleeve of the endoscope shafttogether with an assembly of a flexible member and flex circuit thatextend distally from the inner sleeve and carry the image sensor, anaccelerometer, and LEDs, where the flexible member has first and secondliving hinge portions, and where the outer sleeve is shown with a brokenline.

FIG. 3 is a perspective view of the handle portion of the endoscope ofFIG. 1 with the outer shell removed to show the interior componentsthereof.

FIG. 4A is a view of a distal portion of the endoscope shaft in a first,straight insertion configuration with an outer sleeve in a cut-awaypart-sectional view and an inner sleeve, flexible member, flex circuit,accelerometer, LEDS, and image sensor in an elevational view, whereinthe flexible member, flex circuit and image sensor are in a firstposition within a cylindrical profile or envelope defined by the outersleeve of the shaft, and wherein such an insertion configuration isadapted for insertion through body passageway to a treatment site in apatient's body, for example, a patient's cervical canal that opens to auterine cavity.

FIG. 4B is a cut-away and sectional view of the endoscope shaft of FIG.4A in a second, non-straight configuration wherein the flexible member,flex circuit, and image sensor are in a second position that is movedoutwardly by the spring force of the first living hinge portion and awayfrom the cylindrical envelope defined by the outer sleeve, where such asecond position provides a large cross-section working channel toreceive a straight shaft of a treatment tool.

FIG. 4C is a cut-away and sectional view of the endoscope shaft of FIGS.4A-4B in a third, non-straight configuration wherein the flexible memberis deflected by distal sliding of the outer sleeve, which overcomes thespring force inherent in the second living hinge portion, and where theorientation of the image sensor can be adjusted to a selected angletoward the longitudinal axis of the shaft.

FIG. 5 is an end view of the shaft of the endoscope of FIGS. 1 and 2,showing the insertion profile of the endoscope as well as the diagonaldimension of the image sensor chip and the diameter of the workingchannel relative to the cylindrical insertion profile.

FIG. 6 is a perspective view of the endoscope of FIG. 1 from a differentangle showing the proximal end of the handle and a seal at the proximalend of the working channel.

FIG. 7 is a perspective view of a portion of another variation of anendoscope similar to that of FIGS. 1 and 2 showing an inner sleeve andflexible spring structure carrying an image sensor, where the springstructure has a single living hinge.

FIG. 8A is a view of a distal portion of the endoscope of FIG. 7 in afirst, straight insertion configuration with an outer sleeve and innersleeve in part-sectional views, with the flexible spring structure andimage sensor constrained within the bore of the outer sleeve.

FIG. 8B is a view of the endoscope of FIG. 8A in a second deployedconfiguration with the outer sleeve retracted, and the image sensormoved outwardly and away from the axis of the shaft by the spring forceinherent in the single living hinge portion of the flexible springstructure.

FIG. 9A is a view of another variation of an endoscope similar to thatof FIGS. 1 to 3 with a single piece flex circuit that extends from aproximal tail end outward of the handle, then through the handle andshaft to the distal image sensor and LEDs, with the proximal end of theflex circuit having a connector configured for detachable coupling to acable connector assembly.

FIG. 9B is a perspective view of the distal end of the endoscope of FIG.9A showing the image sensor, two LEDs, and an accelerometer.

FIG. 10 is a perspective view of the flex circuit connector and cableconnector assembly of FIG. 9A separated from one another.

FIG. 11 is a perspective view of the flex circuit connector disconnectedfrom the cable connector assembly of FIG. 10 shown from a differentangle.

FIG. 12 is an enlarged perspective view of the flex circuit connector ofFIG. 10, showing how the flex circuit is formed in the connector housingto align multiple electrical contacts with cooperating contacts in thecable connector assembly.

FIG. 13 is an enlarged perspective view of the cable connector assemblyof FIG. 11, showing a circuit board in the cable connector assemblyhousing.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates an endoscope 100 corresponding to the invention,which includes a proximal handle 106 coupled to a shaft or shaftassembly 110 extending about longitudinal axis 111 to a distal workingend 115. Referring to FIGS. 1 and 2, the shaft includes an outer sleeve120 and an inner sleeve 122 having a passageway or working channel 125therein that extends through the handle 106 and inner sleeve 122 to adistal open end 128. In one variation, the shaft 110 has a diameterranging between 2.5 mm and 10 mm, with a length configured for use inhysteroscopy. More commonly, the shaft diameter is from 3 mm to 6 mm indiameter. The working channel 125, or tool-receiving channel, is adaptedfor receiving various types of tools and typically has a diameterranging between 1 mm and 6 mm, and more often from 2 mm to 4 mm. In use,a tool used in the endoscope can have a straight shaft and comprise abiopsy device, an electrocautery device, an electrosurgical ablationdevice, a resection device, or any other type of tool known in the art.Typically, the endoscope 100 of FIG. 1 is configured for single-use andis not intended for sterilization and re-use.

Referring to FIG. 2, the working end 115 includes a flexible springstructure or member 140, which functions as a leaf spring and is coupledto the distal end 142 of inner sleeve 122, for example, by welding aproximal portion of the flexible member 140 to the distal end 142 ofinner sleeve 122. In one variation shown in FIG. 2, the flexible member140 has proximal leg portions 144 a and 144 b that are welded to innersleeve 122 along weld lines W. Alternatively, the flexible member 140can consist of a machined portion of the inner sleeve 122. As will bedescribed further below, the flexible member 140, as shown in FIG. 2 andFIGS. 4A-4C is configured with first and second living hinge portions145A and 145B, each with an inherent spring force, that are adapted toflex independently to provide a plurality of selected flexed positions.It can be seen that the flexible member 140 has a proximal portion 146that is proximal to living hinge 145A, an intermediate portion 148between living hinges 145A and 145B, and a distal portion 149 that isdistal to the second living hinge 145B.

As can be seen in FIGS. 1 and 2, an image sensor 150 is coupled to adistal end portion 152 of a flex circuit 155 that extends through theshaft 110 and is adjacent to the flexible member 140 in the working end115 (FIG. 2). The term image sensor 150, as used herein, refers to theassembly of a CMOS sensor chip 160, a lens 162 (consisting of anassembly of optical elements), and a sensor housing 164, as can be seenin FIGS. 1 and 2. In the partially exploded view of FIG. 2, the CMOSsensor chip 160 is shown coupled to flex circuit 155, where the recess165 in the sensor housing 164 is dimensioned to receive the sensor chip160. In a variation, the sensor chip 160 is an OmniVision part numberOV9734 CMOS 720p HD PurCel® image sensor available from OmniVisionTechnologies, Inc., 4275 Burton Drive, Santa Clara, Calif. 95054. Thissensor chip 160 has a field of view FOV of 100° about an optical or viewaxis A.

The sensor chip 160 is coupled through cable 168 to an image processor170 and a controller 175 by electrical leads in the flex circuit 155that extends through the shaft 110 and handle 106 to the cable 168. Thecontroller 175 is adapted to control operating parameters of the sensorchip 160 as well as other components of the endoscope 100, as will bedescribed below. The controller 175 and image processor 170 aretypically housed in a console or base unit B (FIG. 1). A video displayor monitor M is also connected to the image processor 170 and controller175 for viewing images from the image sensor 150 (FIG. 1).

As can be seen in FIGS. 1 and 2, the flex circuit 155 and sensor housing164 also carry one or more light emitters, for example, two LEDsindicated at 176A and 176B. Electrical leads in the flex circuit 155connect the LEDs 176A-176B to the controller 175, which includes anelectrical source to provide power to the LEDs. In FIG. 2, it can beseen that LEDs 176A and 176B are connected to two opposing arms 177 aand 177 b of the flex circuit 155. The flex circuit 155 and its arms 177a and 177 b are designed with weakened thickness sections across theflex circuit that allows 90° bends of the angled distal end portion 152that couples to the sensor chip 160 and the arms 177 a and 177 b. Theangled distal flex circuit portion 152 and the arms 177 a and 177 b arebonded to the sensor housing 164 to be maintained in the configurationshown in FIG. 1.

In FIGS. 2 and 4A, it can be seen that the flex circuit 155 also carriesan accelerometer 180 with electrical leads in the flex circuit 155connected to the controller 175 and image processor 170 (FIG. 1). Theaccelerometer 180 sends signals to the controller 175 and imageprocessor 170 regarding movement and orientation of the working end 115,wherein such signals are processed by control algorithms to adjust theimage on the video display or monitor M (FIG. 1) to be maintained in aselected orientation, such as an image-upright orientation, no matterhow the endoscope 100 and working end 115 are rotated. As used herein,the term accelerometer is intended to include any suitable accelerometerand/or gyroscope known in the art, and in one variation is an STMicroIIS2DH three-axis linear accelerometer, and in other variations can beany 3-axis accelerometer or 6 axis IMU (Inertial Motion Unit) with a 3accelerometer axes and 3 gyroscope axes, e.g., an STMicro ISM330DLC,available from STMicroelectronics Inc., 7033 E. Greenway Parkway, Suite300, Scottsdale, 85254, Ariz.

Referring again to FIGS. 2, 3, and 4A, it can be seen that the flexcircuit 155 extends through the shaft 110 in a space or inflow channel185 between the inner surface 186 of outer sleeve 120 and the outersurface 188 of the inner sleeve 122. In one variation best seen in FIG.2, as well as in FIGS. 4A-4C, the flex circuit 155 is configured to passthrough a gap 190 between proximal leg portions 144 a and 144 b of theflexible member 140 such that a superior surface of the flexible member140 is configured with a first deflecting surface or cam surface 195,which may be used to actuate the flexible member 140 as described below.In FIGS. 4A-4C, it can be seen that a second ramp or second cam surface196 is provided on the inferior side of flex circuit 155, which also canalso be used to actuate the flexible member 140. The second deflectingsurface or cam surface 196 can consist of a durable, integrated outerlayer 198 of the flex circuit 155 or can be a metal or polymer elementconnected to the flex circuit 155 (see FIGS. 4A-4B).

Referring now to FIG. 3, the handle 106 is shown with an outer shell 202removed to better view the interior core 206 of the handle 106. It canbe seen in a first Luer fitting 212 is formed as part of the core 206and is in fluid communication with inflow channel 185 as described abovebetween outer sleeve 120 and inner sleeve 122 extending through theshaft 110. A fluid source 220 can be connected to the Luer fitting 212with inflow tubing 222 to provide fluid inflows to the inflow channel185 (see FIG. 2). The fluid source 220 can be a gravity-flow bag or afluid reservoir that is connected to an inflow pump as described below.

Still referring to FIG. 3, a negative pressure source (or outflow pump)225 is connected to outflow tubing 226, which connects to a second Luerconnector 228 formed in the core 206 of the handle 106 that furthercommunicates with the working channel 125 or bore of the inner sleeve122. In FIGS. 1 and 2, it can be seen that the working channel 125 inthe inner sleeve 122 extends through the core 206 of the handle 106 to aproximal opening 235 and a seal 236 in a recess 238 in the proximal endof handle 106. The seal 236 can comprise any type of elastomeric sealknown in the art, such as a duckbill valve or the like, to accommodatethe shaft 240 of a tool inserted through working channel 125 to preventfluid leakage through proximal opening 235.

Now turning to FIGS. 4A-4C, it can be seen how the flexible member 140and image sensor 150 can be moved from a first position, as shown inFIG. 4A to a second position as shown in FIG. 4B and to a range of thirdpositions as shown in FIG. 4C. As can be easily understood, the workingend 115 in the first position of FIG. 4A defines a cylindrical profileCP or envelope that consists of the outer diameter D of the outer sleeve120. This cylindrical insertion profile CP has a lesser cross-sectionand is adapted for atraumatic insertion of the shaft 110 through a bodypassageway into a body cavity, such as inserting the device through apatient's cervical canal into a uterine cavity. In this cylindricalinsertion profile CP, the image sensor 160 and lens 162 have an opticalaxis A and field of view FOV that are angled relative to thelongitudinal axis 111 of the shaft 110 such that the field of view FOVallows visualization of the body passageway as the working end 115 isadvanced through such a body passageway. The optical axis A typicallymay be angled from 10° to 40° away from the longitudinal axis 111(indicated at AA) of the shaft 110 in the first position of FIG. 4A.

FIG. 4B shows the outer sleeve 120 moved in the proximal directionrelative to inner sleeve 122, wherein the flexible member 140 and theimage sensor 160 are moved to a second deployed position in which theimage sensor 160 is moved outwardly and away from the longitudinal axis111 of the shaft 110. As can be understood from FIG. 4B, the distal edge244 of the outer sleeve 120 slides proximally against the firstdeflecting surface 195 of the superior side of flexible member 140, andthe spring force of living hinge portion 145A of the flexible member 140is biased to move from the position of FIG. 4A to the position of FIG.4B. Typically, the flexible member 140 is tensioned in the firstposition of FIG. 4A and non-tensioned in the position of FIG. 4B.Optionally, or in addition, the spring force of living hinge portion145A may be configured such that the tool 242 introduced through theworking channel 125 (broken line in FIG. 2A) contacts the seconddeflecting surface 196 on the flexible member 140 to deflect the livinghinge portion 145A of flexible member 140 to the position shown in FIG.4B. In other words, the living hinge portion 145A can be actuated fromthe position of FIG. 4A to the position of FIG. 4B entirely, orpartially, by the spring force inherent in the living hinge portion 145Aof the flexible member 140.

In FIG. 4B, the non-cylindrical deployed profile DP of the distal end115 has a substantially greater cross-section than diameter D of theshaft 110. The configuration of FIG. 4B moves the image sensor 150 to aposition where the field of view FOV is angled to observe the distal endof tool 242 introduced through the working channel 125 into the bodycavity. In the deployed position of FIG. 4B, the optical axis Atypically may be angled from 0° to 30° away from the longitudinal axis111 of the shaft 110 (see AA′).

FIG. 4C next shows the outer sleeve 120 moved in the distal directionrelative to inner sleeve 122 while the tool shaft 240 remains deployedthrough the working channel 125. As can be easily understood, the firstliving hinge 145A and proximal and intermediate portions 146, 148 offlexible member 140 are locked or constrained in the position of FIG. 4Band distal movement of the distal edge 244 of outer sleeve 120 againstthe first deflecting surface 195 overcomes the spring force inherent inliving hinge portion 145B to deflect the distal portion 149 of theflexible member 140 toward the axis 111 of the shaft 110. It can beunderstood that a range of deployed third positions is possible with oneangled position shown in FIG. 4C, where the optical axis A typically maybe moved to a selected angle ranging from 10° to 45° away from thelongitudinal axis 111 of the shaft 110 (see AA″). Thus, the axialmovement of the outer sleeve 120 can move the flexible member 140 fromthe non-tensioned position of FIG. 4B to a range of tensioned positionsbetween the positions of FIGS. 4B and 4C.

Referring again to FIG. 4C, to return the working end 115 of theendoscope 110 to the insertion or cylindrical profile CP of FIG. 4A, thetool 242 is withdrawn from the working channel, and 125, and the outersleeve 120 is moved in the distal direction relative to the inner sleeve122.

In the variation shown in FIG. 1 and FIGS. 4A-4C, it can be understoodthat the outer sleeve 120 is moved proximally and distally relative tothe inner sleeve 122 by finger grip 252 in the handle 106 that is movedaxially in slot 254. It should be appreciated that relative movement ofthe inner and outer sleeves 120 and 122 can be accomplished either bysliding the outer sleeve 120 axially or by sliding the inner sleeve 122and flexible member 140 in an axial direction.

Referring now to FIGS. 3 and 4A-4C, it can be seen that inflow channel185 extends through the shaft 110 and has a distal open termination 260in the shaft 110 in the first position of FIG. 4A with the cylindricalinsertion profile CP of the working end 115. The inflow channel 185 isused for fluid inflows during insertion of the working end 115 through abody passageway where the fluid inflow can distend and open the bodypassageway as well as provide fluid flows around the sensor lens 162 tomaintain a clear field of view. Referring to FIG. 5, the cross-sectionof space 185 around the image sensor 150 is shown, which provides thefluid inflow pathway in the first position of FIG. 4A. As can beunderstood from FIGS. 4B and 5, the inflow channel 185 remains open inthe second position or deployed profile of the working end 115.

In one variation, the controller 170 includes fluid managementalgorithms that operate an inflow pump 265 connected to the inflowtubing 222 and inflow channel 185 together with the negative pressuresource (outflow pump) 225 coupled to outflow tubing 226 and the workingchannel 125 to provide fluid outflows which then can create acirculating flow through a patient's body passageway or body cavity, forexample, a patient's cervical canal and uterine cavity. The fluidmanagement algorithms can maintain a selected intra-cavity pressure, asis known in the art. In such as system, the outflow tubing 226 can bedetached from the Luer connector 228 and attached to the tool 242 toprovide for fluid outflows through an outflow channel 264 in the toolshaft 240 as is known in the art (see FIGS. 4B-4C).

In another aspect, referring to FIGS. 2 and 5, the design of endoscope100 allows for the use of a sensor chip 160 having a large diagonaldimension DD relative to the cylindrical insertion profile CP of theshaft assembly 110 and working end 115 in the first position of FIGS. 1,2, and 4A (alternatively, the diameter D of shaft 110, outer sleeve120). At the same time, the design of the endoscope 100, when moved tothe deployed profile DP and second deployed position of FIG. 4B allowsfor a working channel 125 extending through the shaft 110 that has alarge channel diameter WCD relative to the cylindrical insertion profileCP (diameter D of shaft 110) of FIGS. 1, 2, and 4A. In one variation,the cylindrical insertion profile CP of FIG. 4A has a diameter of 4.45mm, and the increased cross-section of the deployed profile DP of FIG.4B is 6.23 mm.

Referring to FIGS. 4A and 5, it again can be seen that the endoscopeshaft 110 has a diameter D extending about a longitudinal axis 111 tothe working end 115, a sensor chip 160 with a diagonal dimension DDcarried by the sensor housing 164, and a working channel with diameterWCD extending through the shaft 110, wherein the open passageway 255 inouter sleeve 120 distal from working channel 125 of inner sleeve 122 hasa lesser cross-section in the first position of FIG. 4A and a greatercross-section in the position of FIG. 4B to thus accommodate the tool240 introduced therethrough.

In a variation, the combination of sensor chip's diagonal dimension DDand the working channel diameter WCD are greater than the cylindricalinsertion profile CP (see FIGS. 4A and 5). In such a variation, thediagonal dimension DD of sensor chip 160 has a ratio of greater than0.5:1 relative to the cylindrical insertion profile CP or a ratio ofgreater than 0.6:1 relative to profile CP. In a variation, the workingchannel diameter WCD in the deployed profile DP has a ratio of than0.5:1 relative to the cylindrical profile CP or a ratio of greater than0.6:1 relative to the cylindrical profile CP.

In one variation, the CMOS sensor chip described above (OmniVision partnumber OV9734 CMOS 720p HD PurCel® sensor) has width and heightdimensions of 2.53 mm×1.72 mm with a diagonal dimension DD of 3.06 mm.In this variation, the cylindrical insertion profile CP (or diameter D)is 4.45 mm, and thus the ratio of the sensor chip diagonal DD relativeto the cylindrical profile CP is 0.69:1. In this variation, the workingchannel diameter WCD is 3.02 mm, and thus the ratio of the workingchannel diameter WCD in the deployed profile DP relative to thecylindrical profile CP is 0.68:1.

Referring to FIGS. 1 and 3, a control pad 270 is provided in the handle106 with actuator buttons 272 for operating the endoscope 100, which forexample, can turn on/off the image sensor 160, capture still images,adjust light emitted from the LEDs, etc. In a variation, the control pad270 can also be provided with buttons, toggles, or the like to operatevarious aspects of the fluid management system comprising inflow pump265 and negative pressure source 225, such as flow rates, flush, aselected set pressure and the like. Controls for the endoscope and fluidmanagement aspects of the system can also be provided in the console B(FIG. 1) or on an independent re-usable pad that can be attached to thehandle 106 of the endoscope 100 or in a connector (not shown) thatcouples with cable 168 extending away from the handle 106.

Referring now to FIG. 6, the interior core 206 of the handle 106 isshown from a different angle, with the outer shell 202 of FIG. 1removed. In this view, it can be seen that the working channel 125extends through the handle core 206 to a proximal opening 235 a seal236. The recess 238 in the proximal end of handle core 206 is configuredfor receiving the distal end of a tool and then directing the tool intothe proximal opening 235 and seal into the working channel 125.

FIG. 6 also shows an optional location for an accelerometer 180′, whichagain is coupled to a single flex circuit 155. An accelerometer 180′ inthis location in the handle core 206 can operate as described previouslyto send position signals to the image processor 170 and controller 175.In another variation, a first accelerometer 180 can be located on theflex circuit 155 proximate to the image sensor 150, as shown in FIG. 2,and a second accelerometer 180′ can be located on the flex circuit 155in the handle as shown in FIG. 6. In such a variation, signals from bothaccelerometers 180 and 180′ can be processed to confirm rotationalpositions, or one accelerometer can be used as a backup if signals fromthe other accelerometer fail for any reason.

Now turning to FIGS. 7, 8A, and 8B, another variation of an endoscopeworking end 415 is shown, which is similar to that of FIGS. 1-6. Thevariation of FIGS. 7-8B again has a shaft 410 with an outer sleeve 420and an inner sleeve 422 with working channel 425, where the outer sleeve420 is axially moveable and configured to actuate a metal springstructure 440 between a first cylindrical insertion configuration CP′and a second deployed configuration DP′ (see FIGS. 8A-8B). In thisvariation, the spring structure 440 is simplified and includes a singleliving hinge portion 444. The inner sleeve 422 is coupled with weld W′to the spring structure 440 that carries an image sensor 450 withoptical axis A and field of view FOV is the same as describedpreviously. As can be seen in FIGS. 8A and 8B, the flex circuit 455extends through the shaft 410 in the space or inflow channel 456 betweenthe inner and outer sleeves (420, 422). The image sensor 450 has aninferior surface that is bonded to distal end 458 of the springstructure 440. As can be seen in FIG. 7, a secondary ramp element 460(typically metal) is connected to the spring structure 440 with lateralcouplings 462 a and 462 b. The ramp element is adapted to provide afirst or superior deflecting surface 465. The inferior surface of thespring structure 440 is configured with a second or inferior deflectingsurface 466. Both the deflecting surfaces 465 and 466 may be used toactuate or move the spring structure 440 between the first position ofFIG. 8A and the second position of FIG. 8B. As can be understood fromFIGS. 8A and 8B, in one variation, the inner sleeve 420 can be retractedsuch that the distal edge 470 of outer sleeve 420 slides along superiordeflecting surface 465, and the spring force inherent in a tensionedliving hinge 444 can move the spring structure 440 and image sensor 450to the second position of FIG. 8B. In another variation that can beunderstood from FIG. 8B, a tool 472 can be advanced through the workingchannel 425 such that the tool 472 will contact the inferior deflectingsurface 466 of spring structure 440 and move a partially tensioned ornon-tensioned living hinge 444 to the second position of FIG. 8B. In allother respects, the features of the endoscope 400 of FIGS. 7-8B operatesas described previously. In this variation, an accelerometer 480 isshown coupled to the flex circuit 455 proximal to the image sensor 450.

In the variations of working ends (115, 415) described above, the springstructures (140, 440) and image sensors (150, 450) and the distalportions of flex circuits (155, 455) are illustrated in a skeletal formwhich is economical and suitable for an endoscope used in medicalprocedures. It should be appreciated that such spring structures andimage sensors can be disposed within a housing or elastomeric coveringor molded into an elastomer (not shown) and fall within the scope of theinvention.

In general, an endoscope of the invention comprises a handle coupled toan elongated shaft extending about a longitudinal axis to a distal endthat carries a spring structure or flexible member with an image sensorat the distal end of the shaft, and where the spring structure ismoveable between (i) an insertion position having a first reduced shaftprofile where the field of view is oriented to observe insertion of theshaft through a body passage, and (ii) at least one deployed positionhaving a second expanded shaft profile with the image sensor moved awayfrom the longitudinal axis such that the field of view is oriented toobserve a tool introduced through the working channel into a workingspace. The endoscope further includes at least one LED proximate to theimage sensor that is coupled to the image sensor. Additionally, anaccelerometer is carried by the endoscope positioned proximal to theimage sensor, where the accelerometer is configured to send imagesignals to an image processor, which includes algorithms for displayingimages on a display in a selected orientation no matter what therotational position of the shaft and image sensor may be.

In general, a method of the invention comprises providing a systemincluding an endoscope, image processor, controller and inflow andoutflow pumps, where the endoscope has an axially-extending shaft with adistal spring structure carrying an image sensor, where the springstructure is moveable between (i) a first configuration with a reducedprofile where the sensor's field of view is oriented to observeintroduction of the shaft through a passage in the patient's body, and(ii) at least one second configuration having an expanded profile withthe image sensor moved away from the shaft axis where the field of viewis oriented to observe a tool introduced through a working channeltherein, and wherein the steps of the method include introducing theshaft in the first configuration through a body passageway into aworking space while viewing images from the image sensor, operating theinflow and outflow pumps with the controller to circulate fluid flowswithin the patient's body, moving the spring structure from the firstconfiguration to the second configuration, advancing a tool through aworking channel into the working space, and viewing the tool with imagesfrom the image sensor and performing a treatment in the working spacewith the tool. The method includes using an accelerometer to sendposition signals to the controller and image processor and thenoperating the controller and image processor to continuously adjustimages on a display to a selected orientation, for example, an uprightorientation. The method further includes the step of operating theinflow and outflow pumps to circulate fluid flows while maintaining aselected pressure in the working space.

Now turning to FIGS. 9A and 9B, a variation of an endoscope 100′ areshown that is similar to the endoscope of FIGS. 1 to 3. The endoscope100′ of FIG. 9A has the same handle 106, shaft assembly 110, and imagesensor 160 as in the previous variation of FIGS. 1-3 with the distalworking end 115 of the endoscope shown in FIG. 9B. In FIG. 9A, it can beunderstood that the flex circuit 505 in this variation has a proximaltail portion 506 extending outwardly from the handle 106 to a flexcircuit connector 510. In other words, the flex circuit 505 comprises asingle continuous length of the circuit extending from the flexconnector 510 to the handle 106 and thereafter through the handle 106and shaft 110 to the image sensor 160, LEDs 512A, 512B, and theaccelerometer 180 (FIG. 9B). In the previous variation of FIGS. 1-3, anelectrical cable 168 (FIG. 1) extended into the interior of the handle106 for connection to the flex circuit 155 and at a control pad 270 orcircuit board. In a previous variation (FIG. 6), the handle 106 carrieda circuit board that carried an accelerometer and coupled the electricalleads of an electrical cable to the flex circuit 155.

The single-use endoscope 100′ of FIGS. 9A-9B has the advantage ofeliminating the need for connectors and/or a circuit board in theinterior of the handle 106. In FIG. 9A, an optional control pad 515 andactuator buttons 516 can be provided in the handle 106, which areconnected to the flex circuit 505 for operating the image sensor 160 andLEDs 512A and 512B, similar to that of FIG. 1.

FIGS. 9A and 10 also illustrate that the flex circuit connector 510 isconfigured for detachable coupling to an electrical cable 522, and moreparticularly to a re-useable cable 522 and cable connector assembly 525at the distal end 528 of the cable 522. The proximal end (not shown) ofthe re-usable cable 522 extends to a controller and electrical source asin FIG. 1. As can be seen in FIGS. 10 and 12, the proximal end 540 ofthe flex circuit 505 is disposed in a connector housing 552 of theconnector 510 and has a multi-pin contact member 555, which has from 10to 40 electrical contacts for carrying power to, and signals to andfrom, the image sensor 160, LEDs 512A and 512B, accelerometer 180 andthe optional control pad 515. As can be easily understood, the alignmentand engagement of the flex circuit connector 510 and the cable connectorassembly 525 must be precise due to the very small dimensions of theelectrical contacts therein.

FIG. 11 is a perspective view of the flex circuit connector 510, andcable connector assembly 525 of FIG. 10 rotated from the angle of FIG.10. In FIG. 11, it can be seen that a housing 558 of the cable connectorassembly 525 carries an electrical contact element 560 for engaging themulti-pin contact member 555 of the flex connector 510, as seen in FIG.10. FIG. 12 is an enlarged perspective view of the flex circuitconnector 510 of FIG. 10, showing how the flex circuit 505 is formed andbent within the housing 552.

In FIGS. 12 and 13, it can be seen that the housings 552 and 558 of theconnectors 510 and 525, respectively, are configured with features thatalign the multi-pin contact members 555 and 560. In FIG. 12, it can beseen that dual projecting posts 562 a and 562 b are provided, which areadapted to be received by the receiving bores 564 a and 564 b in thecable connector housing 558, as shown in FIG. 13. Similarly, theexterior rims and of the housings 552 and 555, respectively, have aprojecting element 568A and a receiving form 568B for aligning the twohousings precisely. In FIG. 13, it also can be seen that the cableconnector assembly 525 includes a circuit board 570 that actually cancarry a processor 572 for image processing.

Another aspect of the invention relates to a method of using theendoscope 100′ of FIGS. 9A-9B in a treatment for bladder cancer. Bladdercancer is the most common cancer of the urinary tract, affecting morethan 70,000 people in the US annually. Bladder cancer is the fourth mostcommon cancer among US men. Most men with the disorder havenon-muscle-invasive bladder cancer (NMIBC), where the malignancy has notyet spread to the muscle layer in a bladder wall. A photodynamicdiagnosis of bladder cancer has been developed, where a photosensitizingagent in a liquid formulation (hexaminolevulinate) is introduced intothe patient's bladder through a catheter. The agent is preferentiallyabsorbed by bladder cancer cells. Thereafter, an endoscope that emits ablue light wavelength is used to illuminate the bladder wall. Under suchblue light, the tumors appear bright pink in color, which allows thephysician to more reliably detect such bladder tumors. The physician cantoggle back and forth between white light and blue light to diagnose andresect the tumors. The use of such blue light technology allows for amore complete resection of tumors, which can reduce the chance ofrecurrence and could save lives.

In FIGS. 9A-9B, the endoscope 100′ carries first and second LEDs 512Aand 512B (FIG. 9B) that both can be multi-wavelength emitters that areconfigured to selectively emit a white light or a blue light with awavelength in the range of 360 nm to 405 nm. In one variation, thecontrol panel 515 and actuators 516 in the handle 106 (FIG. 9A) can beused to toggle between the white and blue wavelengths, adjust lightintensity, and/or optionally use one LED to emit white and the other LEDemits blue light. The physician can introduce any type of suitableresecting tool through the working channel to resect the bladder tumor,for example, a resection device of the type shown in commonly-owned andco-pending US Patent Application No. 2021/0128188, an RF ablationdevice, a laser device or an ultrasound device.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly, and any feature may be combined with another in accordance withthe invention. Particular features that are presented in dependentclaims can be combined and fall within the scope of the invention. Theinvention also encompasses embodiments as if dependent claims werealternatively written in a multiple dependent claim format withreference to other independent claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein is merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples or exemplarylanguage (e.g., “such as”) provided herein is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A medical device, comprising: a handle coupled toan elongated shaft with a distal end; an image sensor carried at thedistal end; and a flex circuit with a proximal end having a flex circuitconnector and a distal end electrically coupled to the image sensor,where a proximal tail portion of the flex circuit extends outwardly fromthe handle and a middle portion of the flex circuit extends through thehandle and shaft.
 2. The medical device of claim 1 where the flexcircuit connector is adapted for connecting to a cable connectorassembly at an end of an electrical cable.
 3. The medical device ofclaim 2 where the flex circuit connector includes at least 10 electricalleads configured for connecting to cooperating electrical leads in thecable connector assembly.
 4. The medical device of claim 2 where thecable connector assembly carries a circuit board with a processor. 5.The medical device of claim 4 where the processor is adapted for imageprocessing.
 6. The medical device of claim 1 further comprising is anLED carried at the distal end of the shaft and where a distal end of theflex circuit is electrically coupled to the LED.
 7. The medical deviceof claim 1 further comprising is an accelerometer carried at the distalend of the shaft and where a distal end of the flex circuit iselectrically coupled to the accelerometer.
 8. The medical device ofclaim 7 where the accelerometer is adapted to send position signals to acontroller, and the controller is configured to display images from theimage sensor on a display in a selected orientation no matter arotational position of the shaft and the image sensor.
 9. The medicaldevice of claim 1 further comprising a fluid source in communicationwith a first channel in the shaft configured to provide a fluid inflowinto a treatment site.
 10. The medical device of claim 9 furthercomprising an inflow pump operatively connected to the fluid source forproviding the fluid inflow.
 11. The medical device of claim 10 furthercomprising a second channel in the shaft adapted for connection to anegative pressure source.
 12. The medical device of claim 11 where thenegative pressure source comprises an outflow pump for providing a fluidoutflow from the treatment site.
 13. The medical device of claim 12wherein the inflow pump and the outflow pump are controlled by acontroller to maintain a set pressure in the treatment site.
 14. Themedical device of claim 1 wherein the second channel is configured forintroduction of a tissue treatment tool therethrough.
 15. The medicaldevice of claim 14 wherein the tissue treatment tool comprises at leastone of a grasper, a tissue sealing device, an ablation device and aresection device.